Randomized, Multicentre, Phase III Study in Patients With Intermediate-Risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy
- Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason
score that is less than or equal to 6, as well as a prostate-specific antigen (PSA)
between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated
adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a
PSA equal to or less than 20 (intermediate risk).
- Zubrod performance status score of 0-1
- Patients must sign a consent form before starting the study.
- No evidence of regional disease
- Patients with a previous history of cancer are eligible on the condition that they
have been disease-free for more than five years.
- Non-invasive epidermoid cancers of the skin are eligible.
- The patient must be available for treatments and follow-up visits.
- No evidence of metastatic disease, confirmed by a negative bone scan.
- Severe medical or psychiatric problems that may compromise study compliance
- Chronic hepatic disease; abnormal hepatic function, i.e. AST-ALT > 1.5 times the
upper normal limit.